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|NCT01490060 : Fosaprepitant in Patients Receiving Ifosfamide-based Regimen|
|Ages||Min: 18 Years Max: 65 Years|
1. Patients with sarcoma which is locally advanced, at high risk for relapse or
metastatic for whom treatment with doxorubicin plus ifosfamide (AI) or AI and
vincristine (VAI) is indicated.
2. Must be 18-65 years of age.
3. Male and Females of child bearing potential must use acceptable methods of birth
control which include oral contraceptives, spermicide with either a condom, diaphragm
or cervical cap, us of a intrauterine device (IUD) or abstinence.
4. Adequate hematologic (ANC >/= 1500/mm^3, platelet count >/= 100,000/mm^3), renal
(serum creatinine = 1.5 mg/dL), hepatic (serum bilirubin count = 1.5 x normal and
SGOT or SGPT = 3 x normal) functions.
5. Karnofsky Performance Status >/= 60%
6. Signed informed consent form.
7. Patients are required to read and understand English to comply with protocol
1. Pregnant or lactating women.
2. Patients with any co-morbid condition which renders patients at high risk of
3. Known allergy to fosaprepitant or any of its active components.
4. Patient has uncontrolled angina, congestive heart failure (New York Heart Association
> class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or
hypertension, or acute myocardial infarction within 3 months.
5. Patient has an active seizure disorder. (Patients with a previous history of seizure
disorders will be eligible for the study, if they have had no evidence of seizure
activity, and they have been free of antiseizure medication for the previous 5
6. Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
7. Psychological, social, familial, or geographical reasons that would prevent scheduled
visits and follow-up.
8. Patients receiving any medication for pre-existing nausea/vomiting will be excluded.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01490060
| Link to official Clinicaltrials.gov listing